MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE

Model Number SD980.017

Device Problem Use of Device Problem (1670)

Patient Problem Hypoesthesia (2352)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

The guide was designed and manufactured according to specifications.The fit of the guide was reviewed.Due to the c-shaped area around the mental foramen and the oblique line, the designed fit is unique.

Event Description

Surgeon claims the fit of the guide was not unique, resulting in a surgery delay of 2 hours.Multiple drilling was done.Patient complaints a hypoestesia along the field of innervation of the left inferior alveolar nerve.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 8594217
• MDR Text Key: 144531944
• Report Number: 3003998208-2019-00019
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380174
• UDI-Public: 05420060380174
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K170272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SD980.017
• Device Catalogue Number: ME19ROMNOB
• Device Lot Number: ME19ROMNOB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other